“Such sewage would violate basic infection control and hygiene standards as well as CMS regulations, and certainly could pose a infection risk,” said (Lawrence) Muscarella, who owns LFM Healthcare Solutions and the blog Discussions in Infection Control.”

“In 2014, I suggested and published that this would turn out to be probably a national concern, and possibly a national calamity if proper mitigations were not developed and immediately implemented,” said Bioengineer Dr. Lawrence F. Muscarella, President and Owner of LFM Healthcare Solutions, LLC in Montgomeryville, Pennsylvania.

“Dr. Muscarella says it took the CDC a couple of years to confirm the suspicions that he was raising, that the heater-cooler machines could be a source of spreading different types of infections (including M. abscessus, not only M. chimaera), even when cleaned following the manufacturers recommendations.”

Heater-Cooler Devices: SHEA experts from the University of Iowa Hospitals and Clinics: On January 24, 2017, experts presented an educational webinar on the infection risk associated with contaminated heater-cooler devices. Click here to download this webinar’s slides.

Class 2 recall: May 31, 2016 (Status: open) Action: Fujifilm issued a urgent field correction/Tracking/Verification form on 12/23/2015. Reason: This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for ERCP procedures.

Click here to read more about Dr. Muscarella’s confidential quality and safety services designed to help hospitals (and manufacturers and patients) better understand — and prevent — healthcare-associated infections, including those linked to contaminated GI endoscopes and heater-cooler devices, among other types of contaminated medical devices.

Contaminated medical equipment, such as a duodenoscope or heater-cooler device, should not ordinarily or reasonably be ruled out as a potential reservoir or cause of an infection or outbreak without irrefutable data to the contrary. — Lawrence F Muscarella PhD

TESTIMONIALS:

“Dr. Muscarella, As always, THANK YOU for your efforts and expertise chronicling infection control, transmission, investigations, revelations and insight into solutions. Your site and efforts have single-handedly provided a “One-Stop Go-To” resource allowing medical practitioners, patients, regulators, researchers, stakeholders, attorneys, etc., a most valuable and time-saving reference. You are deserving of the highest award in public service.” — LR, responding to one of Dr. Muscarella’s recent postings. (More testimonials)

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These outbreaks at UCLA and other hospitals could collectively be the most significant instance of disease transmission ever linked to a contaminated reusable medical instrument. — Lawrence F Muscarella, PhD, a hospital-safety consultant in Montgomeryville, Pennsylvania as quoted inThe LA Times (February 18, 2015)

3 comments

Lawrence F Muscarella PhD, writing here along with award winning Health Journalists’ Chad Terhune and Melody Petersen, in LA Times shed light on this tragic problem.
Olympus knew, concealed, had proof, in excess of 15+ years, that many of their scopes, as designed, could not be cleaned. Where was FDA who failed to grant their usual ‘rubberstamp’ of more recent scope designs? Facilities knew when outbreaks occurred yet did nothing, leaving uninformed patients at risk of dying.
The Senate report is critically important. It defines the problem and presents solutions. http://www.help.senate.gov/imo/media/doc/Duodenoscope%20Investigation%20FINAL%20Report.pdf
The simple conclusion:
“A passive device surveillance system is ineffective even when manufacturers and hospitals self​ ​report information about device​ safety to FDA​”​
“Even when” misleads when the report clearly acknowledges both manufacturer and facility reporting are severely lacking.
Charting device serial numbers, scanning barcoded device entries to insurance documentation as is now required for pharmaceutical and blood products should be required by law. Inspections to ensure compliance? YES. Ignoring the problem will not make it disappear. Healthcare facilities, of all entities, should be spearheading compliance to lessen overall escalating infections, reducing healthcare costs, saving lives.
“First do no harm.”

This sentence in particular is very concerning:
“In these instances MEDIVATORS has removed the ability to monitor the specific channels from the software parameter set to eliminate false alarms related to disconnection and blockage anomalies. Users reprocessing these endoscopes should check for blockages in the pertinent channels during the manual cleaning process. Then during reprocessing in the ADVANTAGE, any channel that is found disconnected at the completion of the reprocessing cycle should be reconnected and the entire endoscope reprocessed again”

I am aware of at least two models listed which are in regular use at our hospital.

Lawrence, what is your advice concerning the lack of complete channel monitoring/alarming offered by the Medivators Advantage endoscope reprocessor? What are the dangers of manually checking for blockages and how can we prevent human error?